Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations

This is a very early study, called a Phase 1 trial, for a new drug known as ATV-1601. It's designed for adult patients who have advanced solid cancers, particularly advanced breast cancer, where the cancer cells have a particular genetic change (mutation) called AKT1 E17K. The main purpose of this study is to find out if ATV-1601 is safe for people and what dose can be given without causing too many side effects. Doctors will also start to see how the drug is handled by the body and if it shows any signs of helping against the cancer. Being a first-time-in-humans study, it's focused on safety and understanding the drug's basic effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Atavistik Bio Inc.

Enrolment target

Start

15 Sep 2025

Advanced solid tumors Breast Cancer

What is this study about?

This study is about a new medicine called ATV-1601 for people with advanced cancer. Cancer is considered 'advanced' when it has spread from where it started to other parts of the body, or when it has come back after treatment. This particular study is for cancers that have a specific genetic change, or 'mutation', called AKT1 E17K. This mutation is like a tiny error in the cancer's instruction manual that can make it grow.

Because this is a 'Phase 1' study, it's one of the first times this new medicine is being tested in humans. The main goal during this phase is to make sure the medicine is safe and to figure out what dose people can take without experiencing too many side effects. It's also a chance for the doctors to learn how the body uses and processes the medicine.

While this study is primarily about safety and dosage, the researchers will also be looking to see if there are any early signs that the medicine might be effective against the cancer. This kind of research is very important because it helps to develop new treatments for cancers that are difficult to treat with current options.

Key takeaways

This is an early-stage (Phase 1) study for a new cancer medicine called ATV-1601.
It's for adults with advanced solid cancers, especially breast cancer, with a specific genetic change (AKT1 E17K mutation).
The main aims are to check the medicine's safety and find the best dose.
You would receive the new medicine and have regular check-ups.
Potential benefits include access to a new treatment, but there are unknown risks and side effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you must be an adult aged 18 or older. Both men and women can take part. A key requirement is that you must have an advanced solid cancer, which means the cancer started in an organ and has either spread or come back.

Crucially, your cancer must also have a specific genetic change known as an AKT1 E17K mutation. This is a very specific type of change that your doctor can test for. The study is particularly looking for people with advanced breast cancer who have this mutation, but other solid cancers with this mutation might also be included. Your medical team will need to confirm if you meet all the necessary health and cancer-related criteria to be eligible for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of advanced solid cancer?
Has your doctor confirmed your cancer has an AKT1 E17K genetic mutation?
Are you generally well enough to take part in a study?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the hospital or clinic. These visits will involve various tests and checks to monitor your health and how the medicine is affecting you. This might include blood tests, physical examinations, and scans to check your cancer. You will be given the study medicine, ATV-1601, according to a schedule set by the study doctors.

Because this is a new medicine, the doctors will pay close attention to any changes in your health or any side effects you might experience. There will also be follow-up appointments after you stop taking the medicine to ensure your well-being. The total length of your participation will depend on how you respond to the treatment and the study plan, but Phase 1 studies can involve several months of active treatment and follow-up.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be access to a new medicine that isn't yet widely available, which might help your cancer when other treatments haven't worked or aren't suitable. However, because this is a new medicine, the exact side effects and how well it works are not fully known. There is a risk of experiencing side effects, which could range from mild to serious. The study team will explain all known and potential risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Italy
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Unverified
Spain
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Unverified
France

Common questions

What does 'Phase 1 study' mean?

It means this is one of the first times this new medicine is being tested in people. The main goals are to check its safety and find the right dose.

What is an 'AKT1 E17K mutation'?

It's a specific genetic change found in some cancer cells that can make them grow. Your doctor can test if your cancer has this.

Will this medicine cure my cancer?

It's too early to say. Phase 1 studies mainly focus on safety. While researchers hope it helps, curing cancer is not the main goal at this stage.

What if I experience side effects?

The study team will closely monitor you and manage any side effects. You should always tell them about any changes you notice in your health.

Is travel to the study site covered?

You should discuss any potential costs, like travel or parking, with the study team as each study has different policies.